Core Viewpoint - Co-Diagnostics, Inc. and CoSara Diagnostics have achieved ISO 13485:2016 certification for their quality management system, which is essential for regulatory clearance of their new PCR platform and other medical devices [1][2][4] Group 1: Certification and Compliance - CoSara has successfully completed audits of its quality management system, leading to the ISO 13485:2016 certification for its manufacturing facility in Vadodara, India [1][2] - The certification is a significant milestone that validates the efforts of CoSara's Quality team in maintaining high international standards [2] - ISO 13485 certification ensures compliance with best practices in medical device manufacturing, facilitating market access and enhancing stakeholder trust [2] Group 2: Regulatory and Market Implications - The certification is crucial for demonstrating compliance to regulatory bodies in India and internationally, aiding in the clearance of the upcoming PCR platform and other medical devices [2][4] - The Co-Dx PCR platform, which includes various products, is currently under review by the FDA and is not yet available for sale [5] - Manufacturing under the 'Make in India' initiative will provide cost advantages compared to importing products into India [4] Group 3: Development and Future Plans - Recent visits by Co-Dx staff to India were aimed at finalizing software for tuberculosis and HPV tests, as well as supporting manufacturing lines for commercialization [3] - The completion of audits aligns with ongoing efforts to prepare for clinical performance studies and regulatory submissions [3][4]